Baseline HbA1c Levels Research Articles

Do hybrid closed loop insulin pump systems improve glycemic control and reduce hospitalizations in poorly controlled type 1 diabetes?

Hybrid closed-loop (HCL) systems improve glycemic control in type 1 diabetes mellitus (T1D), but their effectiveness in young, poorly controlled populations is notestablished and requires study. A pre-post study was performed using electronic health records of patients 3-24 years with baseline HbA1c≥9 % prescribed HCL within the New York City Health+Hospitals System assessing HbA1c levels and hospitalizations before and after HCL initiation and factors associated with achieving HbA1c<9 % after HCLinitiation. Of 47 children and adolescents who met inclusion criteria, 4.68 % female, 95.72 % non-White, and 82.22 % covered by public insurance, with a baseline average HbA1c10.6 % (2.28 IQR). The most prevalent pump type wasOmnipod 5 (70.21 %). The HbA1c was significantly lowerinthe postperiod than baseline (HbA1c before=median 10.6 (IQR2.28), HbA1c after=median 9.33 (IQR 2.97), difference 1.00 (IQR 1.64), p<0.05) with a decrease in median diabetes-related hospitalizations (preperiod 1.00 (IQR 1.00), postperiod 0.00 (IQR 1.00), difference-1.00, IQR 2, p<0.05). Lower baseline HbA1c levels made reaching HbA1c<9 % more likely. Multivariable analysis showed thatthe odds of having HbA1c of <9 % was 2.1 times less likely for every one point increase in baseline HbA1c and 12.5 times less likely for those with a pump at (p<0.05). HCL therapy improved glycemic control and decreased diabetes-related hospitalizations in youth with poorly controlled T1DM. Higher baseline HbA1c levels predicted less success with HCL therapy so those who standto benefit most benefit least.

Real-Life Achievements of MiniMed 780G Advanced Closed-Loop System in Youth with Type 1 Diabetes: AWeSoMe Study Group Multicenter Prospective Trial.

Background: We assessed real-life glycemic outcomes and predictors of composite measures of optimal glycemic control in children and adolescents with type 1 diabetes (T1D) during their initial 12 months of the MiniMed™ 780G use. Methods: This prospective observational multicenter study collected demographic, clinical, and 2-week 780G system data at five time points. Optimal glycemic control was defined as a composite glycemic control (CGC) score requiring the attainment of four recommended continuous glucose monitoring (CGM) targets, as well as the glycemia risk index (GRI) of hypoglycemia and hyperglycemia and composite CGM index (COGI). Outcome measures included longitudinal changes in multiple glycemic parameters and CGC, GRI, and COGI scores, as well as predictors of these optimal measures. Results: The cohort included 93 children, 43% girls, with a median age of 15.1 years (interquartile range [IQR] 12.9,17.0). A longitudinal analysis adjusted for age and socioeconomic index yielded a significant improvement in glycemic control for the entire cohort (ptime < 0.001) after the transition to 780G. The mean hemoglobin A1c (HbA1c) (SE) was 8.65% (0.12) at baseline and dropped by >1% after 1 year to 7.54% (0.14) (ptime < 0.001). Optimal glycemic control measures improved at 12 months post 780G; CGC improved by 5.6-fold (P < 0.001) and was attained by 24% of the participants, the GRI score improved by 10-fold (P = 0.009) and was achieved by 10% of them, and the COGI improved by 7.6-fold (P < 0.001) and was attained by 20% of them. Lower baseline HbA1c levels and increased adherence to Advanced Hybrid Closed-Loop (AHCL) usage were predictors of achieving optimal glycemic control. Conclusions: The AHCL 780G system enhances glycemic control in children and adolescents with T1D, demonstrating improvements in HbA1c and CGM metrics, albeit most participants did not achieve optimal glycemic control. This highlights yet ongoing challenges in diabetes management, emphasizing the need for continued proactive efforts on the part of health care professionals, youth, and caregivers.

In adults with BMI ≥27 kg/m2 and CVD, but without diabetes, semaglutide reduced MACE, regardless of baseline HbA1c level.

Lingvay I, Deanfield J, Kahn SE, et al; SELECT Trial Investigators. Semaglutide and cardiovascular outcomes by baseline HbA1c and change in HbA1c in people with overweight or obesity but without diabetes in SELECT. Diabetes Care. 2024;47:1360-1369. 38907684.

GLP1-RA versus DPP4 inhibitors on cardiovascular outcomes: A three-year real-world analysis

Abstract Background Cardiovascular outcome trials of GLP1-RAs have massively impacted the clinical practice in the management of patients with type 2 diabetes. The cardiovascular protective properties of GLP1-RA compared to DPP4 have been demonstrated in an observational setting before, however recent methodological developments have enabled clinically relevant effect estimation. Aim This study aimed to evaluate the real-world cardiovascular outcomes of GLP1-RA versus DPP4 inhibitors in patients with type 2 diabetes and high cardiovascular risk. Methods In this study, we utilized the Danish nationwide registers to identify new users of GLP1-RA or DPP4 therapies from 2012 to 2022. Participants were required to be either at least 50 years of age and have one or more of the following conditions: hypertension, chronic obstructive pulmonary disease, cardiovascular disease, or chronic renal disease or be at least 60 years of age and have hypertension. Additionally, their glycated hemoglobin (HbA1c) levels needed to be 53 mmol/mol or higher within the year preceding their first prescription date for these therapies. The index date was defined as the initial prescription date, and comorbidities and medicine use were evaluated up to 10 years prior to this date. Individuals who had filled prescriptions for SGLT2 inhibitors within six months prior to their index date were excluded from the study. The outcome of interest was a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke (MACE). Patients were followed for up to three years until MACE, all-cause mortality, emigration, or until the end of follow-up on December 31, 2022. To assess the three-year risk of MACE, the Aalen Johansson estimator was used. A casual inference framework was employed estimating the three-year average treatment effect using g-formula based on Cox regression with competing risk. Results A total of 26,190 individuals were included, with 19,494 initiating DPP4 inhibitor therapy and 6,696 initiating GLP1-RA therapy. The three-year risk of MACE was 8.56% (95% confidence interval [CI]: 8.11 to 9.00) for the DPP4 initiator group, compared to 4.76% (95% CI: 4.08 to 5.43) for the GLP1-RA initiator group. Emulating what would have happened had all included individuals initiated GLP1-RA treatment versus had all initiated treatment with DPP4, accounting for age, sex, income, education, degree of urbanization, diabetes duration, baseline hba1c level, co-medicine, and co-morbidities, we estimated an three-year average treatment effect of -2.05% (95% CI:-2.92;-1.18) , p-value&amp;lt;0.001) for GLP1-RA initiation versus DPP4 initiation for MACE. Conclusion Our findings suggest that GLP1-RA use is associated with a significantly lower risk of MACE compared to DPP4 inhibitors in a real-world population of patients with type 2 diabetes and high cardiovascular risk. This supports the cardiovascular protective role of GLP1-RA in clinical practice.

Effects of SGLT-2i and GLP-1RA in vascular function parameters: the impact of the weight loss

Abstract Background Arterial stiffness and endothelial function markers flag increased cardiovascular disease risk in patients with type 2 Diabetes Mellitus (T2DM), while weight management plays a crucial role for the management of glycemic control and prevention of complications in these patients. Purpose To investigate the effects of novel antidiabetic agents on arterial stiffness and endothelial function as well as the metabolic parameters of HbA1c and Weight in T2DM patients. Patients and Methods: We enrolled 99 consecutive patients under stable antidiabetic therapy who did not reach therapeutic targets. Subjects were assessed to receive an additional antidiabetic agent to optimize glucose control; glucagon like peptide-1 receptor agonist (GLP-1RA, n=50) or sodium/glucose cotransporter-2 inhibitor (SGLT-2i, n=49). Glycosylated hemoglobin (Hba1c) and weight expressed through Body Mass Index (BMI) along with carotid-femoral pulse wave velocity (PWV) and flow-mediated dilatation (FMD), as biomarkers of arterial stiffness and endothelial function accordingly, were measured at baseline and 3 months after treatment intensification. Results There were no differences between the study groups in traditional risk factors of age and sex or baseline HbA1c, BMI, PWV, and FMD levels (ps=NS for all). In both groups PWV values displayed a statistically significant improvement from 11.2±2.5 to 9.3±2.2 m/sec (p&amp;lt;0.001) in the GLP-1RA group and from 10.7±2.4 to 8.9±2.0 m/sec (p=0.001) in the SGLT-2i group, as presented in Figure 1 through the differences in the values of PWV. FMD values were also significantly improve in both groups from baseline to follow-up; from 6.04±1.22 to 6.50±1.26% (p&amp;lt;0,001) for the GLP-1RA group and from 6.38±1.21 to 6.81±1.29% (p&amp;lt;0.001) for the SGLT-2i group. Moreover, both groups achieved better weight management goals in terms of BMI values between baseline and follow-up; from 33.6±4.9 to 31.5±4.6 kg/m2 for the GLP-1RA group (p&amp;lt;0.001) and from 31.8±5.5 to 30.5±5.6 kg/m2 for the SGLT-2i group (p&amp;lt;0.001), in addition to achieving better glycemic control in terms of HbA1c values, as seen in their paired differences: for GLP-1RA: 1.3±0.7% and for SGLT-2i: 0.8±0.5%. Interestingly, in the SGLT-2i group the magnitude of the PWV improvement was correlated with the weight loss (r=0.368, p=0.007). Conclusion These data provide evidence that the newer antidiabetic drugs, both GLP1-RA and SGLT-2i, have actions that benefit both vascular function, endothelium as well as metabolic parameters. Interestingly, in the patients receiving SGLT-2i the magnitude of the PWV improvement was correlated with the weight loss.delta PWV for SGLT-2i &amp; GLP-1RA groupsCorrelation of deltaWeight &amp; deltaPWV

Implications of baseline glycemic control by plasma glycated hemoglobin A1c on adverse outcomes in patients with coronary heart disease and type 2 diabetes mellitus: Results from the PROMISE study

BackgroundThe optimal glycosylated hemoglobin (HbA1c) target in type 2 diabetes mellitus (T2DM) patients remains controversial, especially in patients with concomitant coronary heart disease (CHD). This study aimed to investigate the correlation between baseline HbA1c and long-term prognosis in CHD patients with T2DM. MethodsThe study enrolled 6,839 CHD patients with T2DM and measured HbA1c at admission in a multicenter prospective observational cohort. Patients were divided into two groups according to baseline HbA1c levels: optimal glycemic control group (HbA1c < 7.0 %, n = 3023) and poor glycemic control group (HbA1c ≥ 7.0 %, n = 3816). The study endpoints were all-cause death and major adverse cardiac and cerebrovascular events (MACCEs). ResultsThe median follow-up period was 2.1 years. During this period, 229 (3.3 %) all-cause deaths, 165 (2.4 %) cardiac deaths, and 759 (11.1 %) MACCEs occurred. Unadjusted Kaplan–Meier analysis showed that the incidences of all-cause death, cardiac death, non-fatal MI, unplanned revascularization, and MACCEs were significantly lower in the HbA1c < 7.0 % group than in the HbA1c ≥ 7.0 % group (P < 0.05). Multivariate Cox hazard analysis indicated that the incidences of all-cause death, cardiac death and MACCEs were significantly lower in the HbA1c < 7.0 % group compared to the HbA1c ≥ 7.0 % group [all-cause death: hazard ratio (HR) 1.969, 95 % confidence interval (CI) 1.421–2.729; cardiac death: HR 2.515, 95 % CI 1.647–3.839; MACCEs: HR 1.345, 95 % CI 1.150–1.573; P < 0.001]. ConclusionsBaseline HbA1c level was associated with all-cause death, cardiac death, and MACCEs in CHD patients with T2DM.

Model-based meta-analysis of HbA1c reduction across SGLT2 inhibitors using dose adjusted by urinary glucose excretion

This study was aimed to evaluate whether the dose–response relationship of the sodium glucose co-transporter-2 inhibitors (SGLT2is) in patients with type 2 diabetes mellitus (T2DM)—canagliflozin, dapagliflozin, empagliflozin, ipragliflozin, luseogliflozin, and tofogliflozin—can be explained in a unified manner based on their ability to promote urinary glucose excretion (UGE). Information on HbA1c reduction at various doses of each SGLT2i was collected from literatures on randomized controlled trials and was normalized based on the daily UGE data from phase I studies. After normalizing doses, the dose–response relationship of HbA1c reduction of most of SGLT2is was represented by a unified nonlinear mixed-effect model, with the estimated maximum HbA1c (%) reduction (Emax) of 0.796 points, whereas covariate analysis showed that canagliflozin had a 1.33-fold higher Emax than those of the other drugs. Other covariates included baseline HbA1c levels, body weight, disease duration, prior treatment, and renal function. Findings from this study would influence drug selection and adjustment in clinical practice. As with SGLT2is, in cases where the efficacy cannot be easily evaluated but an appropriate pharmacodynamic marker was assessed in early clinical trials, similar approaches for other drug classes can guide strategic and evidence-based dose selection in phase III trials.

The Association of Glycemic Control Medication Regimens and Preoperative Fructosamine Among Total Joint Artrhoplasty Patients.

Although glycated hemoglobin A1C (HbA1c) has classically been used for glycemic control screening before surgery, fructosamine, a short-term glucose variability indicator, has been reported to be a more accurate predictor of postoperative periprosthetic joint infection among patients with diabetes mellitus (DM). Given the variability of diabetic medication management, this study aims to identify the associated effect of glycemic control medication regimen (GCMR) on the incidence rate and associated odds of abnormal preoperative fructosamine levels among diabetic primary total knee arthroplasty or total hip arthroplasty patients. Between 2017 and 2018, consecutive series of total hip arthroplasty and total knee arthroplasty patients were identified, and the final cohort included only diabetic patients. All patients reported preoperative HbA1c and fructosamine levels. GCMR categories included insulin, metformin, and other. Independent risk of GCMR and abnormal fructosamine levels (>293 µmol/L) were identified using multivariable logistic regression, while controlling for preoperative baseline factors including HbA1C. Among 420 patients, 15.7% (66/420) were diabetic, of whom 22.7% (15/66) reported an abnormal fructosamine level. Among patients requiring GCMR, 24.0% (18/75), 56.0% (42/75), and 77.7% (58/75) reported using insulin, other, and metformin, respectively. Multivariable logistic regressions demonstrated that insulin-dependent patients with DM reported a 1.71 (95% confidence interval [CI], 0.096 to 30.213, P = 0.716) increased odds of abnormal fructosamine levels compared with nonactive GCMR patients, whereas patients managed with metformin and other glycemic control medications reported a protective 0.48 (95% CI, 0.418 to 5.407, P = 0.549) and 0.32 (95% CI, 0.216 to 4.508, P = 0.393) decreased odds of abnormal fructosamine levels, respectively. In this study, insulin and other GCMR medications exhibited a trend for increased and decreased odds of having abnormal preoperative fructosamine levels while controlling for baseline HbA1c level compared with patients with DM without active GCMR. This association may be explained by multifactorial short-term glucose variability in insulin users, indicating the continued need and optimization of short-term glycemic variations instead of HbA1c.

Glycemic indicators and mental health symptoms: results from the greater Beirut area cardiovascular cohort.

Depression and anxiety present high and complex comorbidity with diabetes. One proposed explanation is that glycemic dysregulations and diabetes-related processes can influence mental health risk. We examined the associations of concurrent and prior glycemic indicators (Hemoglobin A1c (HbA1c) and fasting blood glucose (FBG) levels) with depression and anxiety symptoms in a community-based sample of middle-aged Lebanese adults. Data come from the Greater Beirut Area Cardiovascular Cohort (GBACC), with baseline and 5-year assessments of sociodemographic, lifestyle, and biological factors (n=198). Depression (Patient Health Questionnaire-9) and anxiety (General Anxiety Disorder-7) symptoms were assessed at follow-up. We investigated associations between glycemic indicators and continuous mental health scores using first linear and then piecewise regression models. Adjusted piecewise regression models showed different associations with mental outcomes across glycemic indicators in the diabetic/clinical compared to the non-diabetic range: Among participants with <126 mg/dl baseline FBG, higher FBG levels in this range were significantly associated with lower depressive (beta=-0.12, 95%CI= [-0.207, -0.032]) and anxiety symptoms (beta=-0.099, 95%CI= [-0.186, -0.012]). In contrast, among participants with baseline FBG levels ≥126 mg/dl, higher FBG levels were significantly associated with higher anxiety symptoms (beta=0.055; 95%CI= 0.008, 0.102). Higher baseline FBG levels in the ≥126 mg/dl range showed a not statistically significant trend for higher depressive symptoms. Although not significant, baseline HbA1c levels showed similar patterns with negative associations with mental health symptoms in the <6.5% range. Results show that FBG levels were associated with poorer mental health symptoms only in the clinical/diabetic range, and not in the normal range. Associations were observed with baseline glycemic indicators, highlighting potentially early and prolonged associations with mental health. Findings highlight the importance of clinical changes in glycemic indicators for mental health and motivate further research into the transition toward adverse associations between diabetes and mental health.

Effectiveness and Safety of the TRIO Optimal Health Management Program in Patients with Type 2 Diabetes Mellitus (T2DM) Initiating Basal Insulin Therapy: Real-World Study.

Diabetes, a chronic disease necessitating long-term treatment and self-management, presents significant challenges for patients who spend most of their treatment time outside of hospitals. The potential of digital therapeutics for diabetes has garnered recognition from different organizations. Although some prior studies have demonstrated successful reductions in patients' blood glucose levels and body weight through digital diabetes programs, many studies were limited by including prediabetes patients, patients treated with mostly premixed insulin, or evaluating user engagement outcomes rather than clinical outcomes. Consequently, limited evidence remains regarding the effectiveness of health management mobile applications specifically designed for T2DM patients initiating BI (basal insulin). Based on this, a data-based and artificial intelligence management system named TRIO was developed to provide patients with more personalized intervention methods in stages, groups, and around the clock. TRIO assists doctors and nurses in achieving better blood glucose controls, truly carries out standardized management around patients, and allows them to have a higher quality of life. TRIO represents the three essential pillars in comprehensive diabetes management: physician, nurse, and patient. This prospective observational study evaluated the effectiveness and safety of the TRIO optimal health management program for patients with type 2 diabetes mellitus (T2DM) initiating basal insulin therapy in a real-world setting. Patients aged 18 to 85 with inadequate glycemic control (baseline HbA1c ≥7.0%) starting basal insulin therapy were enrolled in outpatient and inpatient settings. The study was 3 months, with health education and phone-based follow-up assessments. Data collected included patient characteristics, medical history, baseline diabetes conditions, treatment compliance, glycemic control, and safety indicators. A total of 199,431 patients were included, and 118,134 patients completed the 3-month follow-up between Dec 1, 2019, and Dec 31, 2021, involving 574 hospitals in China. The mean baseline HbA1c was 9.2%, the mean duration of diabetes was 7.3 years, and 80.4% of patients were using basal insulin with oral antihyperglycemic drugs. After the intervention, mean HbA1c decreased by -2.59% from baseline, with 55.6% achieving the target HbA1c level of <7.0%. Patients who set lower fasting plasma glucose (FPG) goals (<6.1 mmol/L) showed more significant HbA1c reductions and higher target achievement compared to those with FPG goals≥6.1 mmol/L. Factors such as complications, diabetes duration, and baseline HbA1c levels influenced the magnitude of HbA1c reduction. The presence of complications, shorter diabetes duration, and higher baseline HbA1c were significantly associated with increased hypoglycemia incidence risk. The TRIO optimal health management program effectively improved glycemic control in patients with T2DM initiating basal insulin therapy. Individualized treatment approaches considering patient characteristics and glycemic goals are vital for optimal outcomes. This real-world study was approved by the Ethics Committee of Nanjing Drum Tower Hospital (IRB Review Approval Document, Code: 2019-231-01).

7490 Comparative Clinical Analysis of DPP-4 inhibitors and SGLT2 inhibitors; Switch Study in Real-World Setting

Abstract Disclosure: H. Choe: None. M. Kwak: None. J. Lee: None. Y. Choi: None. E. Hong: None. Objective: Dipeptidyl peptidase-4 inhibitors (DPP-4i) and sodium-glucose cotransporter-2 inhibitors (SGLT2i) represent two distinct pharmacological pathways in the management of type 2 diabetes, both aiming to improve glycemic control without risk of hypoglycemia. Metabolic implications and glycemic control associated with the interchange between SGLT2i and DPP-4i are scarce. This study aimed to evaluate the effect of switching between SGLT2i and DPP4i on various clinical parameters in Korean patients with type 2 diabetes. Methods: We conducted a retrospective cohort study at Hallym University Dongtan Sacred Heart Hospital, using clinical data warehouse. Baseline measurements and follow-up data at 3 months were collected for parameters including hemoglobin A1c (HbA1c), blood pressure, lipid profile, liver enzymes, renal function, and other metabolic markers. Results: Between 2015 and 2023, 104 participants switched from SGLT2 inhibitors to DPP4 inhibitors, while 321 switched in the opposite direction. Initially, those who switched from SGLT2 inhibitors to DPP4 inhibitors presented with lower baseline HbA1c levels (7.22 ± 0.73% versus 7.42 ± 0.76%, P = 0.017) and higher estimated glomerular filtration rates (eGFR) (95.2 ± 23.1 versus 85.9 ± 23.7 mL/min/1.73m², P = 0.001) compared to those who switched from DPP4 inhibitors to SGLT2 inhibitors. At three months of follow-up, the SGLT2 inhibitors to DPP4 inhibitors group exhibited a more significant reduction in HbA1c (adjusted β 0.22, 95% CI 0.03 to 0.40, P = 0.023), especially in patients with reduced eGFR (&amp;lt;60 mL/min/1.73 m²) (β 1.2, 95% CI 0.30 to 2.11, P = 0.013; P for interaction = 0.005). On the other hand, the DPP4 inhibitors to SGLT2 inhibitors group showed a greater decrease in fasting glucose levels (β -9.73, 95% CI -17.6 to -1.86, P = 0.016), along with more pronounced reductions in liver enzymes AST (β -4.15, 95% CI -6.49 to -1.81, P &amp;lt; 0.001) and ALT (β -6.42, 95% CI -9.58 to -3.27, P &amp;lt; 0.001), and a significant increase in hematocrit (β 3.31, 95% CI 2.36 to 4.26, P &amp;lt; 0.001) compared to the initial group. Conclusions: The study concludes that in Korean patients with type 2 diabetes, switching from SGLT2 inhibitors to DPP4 inhibitors is associated with a greater reduction in HbA1c, particularly in those with reduced renal function. Conversely, switching from DPP4 inhibitors to SGLT2 inhibitors results in more substantial improvements in fasting glucose and liver enzyme levels, suggesting differential benefits depending on the direction of the medication switch. Presentation: 6/3/2024

The Supporting Emerging Adults With Diabetes (SEAD) Program: An Adult-Based Real-World Clinical Model That Improves Hospitalizations, Diabetes Technology Uptake, and Glycemic Outcomes in Underserved Young Adults With Type 1 Diabetes.

Underserved young adults (YA) with type 1 diabetes (T1D) experience the worst outcomes across the life span. We developed and integrated the Supporting Emerging Adults with Diabetes (SEAD) program into routine endocrinology care to address unmet social and medical challenges. This study was designed as a longitudinal cohort study, with prospective data collection over 4 years on YA in SEAD compared with usual endocrine care. We used propensity-weighted analysis to account for differences in baseline characteristics, and multivariate regression and Cox proportional hazard models to evaluate change in outcomes over time. Primary outcomes included incidence of hospitalizations, diabetes technology uptake, and annual change in HbA1c levels. We included 497 YA with T1D in SEAD (n = 332) and usual endocrine care (n = 165); mean age 25 years, 27% non-Hispanic Black, 46% Hispanic, 49% public insurance, mean HbA1c 9.2%. Comparing YA in SEAD versus usual care, 1) incidence of hospitalizations was reduced by 64% for baseline HbA1c >9% (HR 0.36 [0.13, 0.98]) and 74% for publicly insured (HR 0.26 [0.07, 0.90]); 2) automated insulin delivery uptake was 1.5-times higher (HR 1.51 [0.83, 2.77]); and 3) HbA1c improvement was greater (SEAD, -0.37% per year [-0.59, -0.15]; usual care, -0.26% per year [-0.58, 0.05]). SEAD meaningfully improves clinical outcomes in underserved YA with T1D, especially for publicly insured and high baseline HbA1c levels. Early intervention for at-risk YA with T1D as they enter adult care could reduce inequity in short and long-term outcomes.

Real-time continuous glucose monitoring vs. self-monitoring of blood glucose: cost-utility in South Korean type 2 diabetes patients on intensive insulin

Aims This study investigated the cost-utility of real-time continuous glucose monitoring (rt-CGM) versus self-monitoring of blood glucose (SMBG) in people with type 2 diabetes (T2D) receiving intensive insulin therapy in South Korea. Methods The IQVIA Core Diabetes Model (CDM v9.5) was used, with clinical effectiveness data obtained from a large-scale real world study. Costs were obtained from South Korean sources and inflated to 2022 South Korean Won (KRW). A South Korean payer perspective was adopted over a lifetime horizon, with future costs and effects discounted at 4.5% per annum. Baseline characteristics included a mean baseline HbA1c level of 8.6% (71 mmol/mol), and a mean age of 64.4 years. A willingness-to-pay (WTP) threshold of KRW 46.0 million was used. Results Rt-CGM led to an increase of 0.683 quality-adjusted life years (QALYs) versus SMBG (7.526 QALYs for rt-CGM versus 6.843 QALYs for SMBG). An increase in costs of KRW 16.4 million (from KRW 90.4 million to KRW 106.8 million) was associated with rt-CGM. The incremental cost-utility ratio was KRW 24.0 million per QALY gained, significantly lower than the KRW 46 million threshold. Conclusions For individuals with T2D managed by intensive insulin therapy in South Korea, rt-CGM is cost-effective relative to SMBG.

Chronic Work Discrimination, Allostatic Load, and HbA1c in Older Workers.

Work discrimination is an important public health problem with consequences for health. This study examined the effect of chronic work discrimination on 4-year changes in HbA1c, as a reflection of glucose control and type 2 diabetes risk in older workers and assessed whether allostatic load (AL) affected the strength of this association. We used Health and Retirement Study data (2010-2016, n = 3,246). Conditional change multinomial logistic regression examined the association between chronic work discrimination, high AL (4 or more out of 8 high-risk biomarkers), and HbA1c, while accounting for relevant covariates. Black participants had the highest rates of baseline (22.7%) and follow-up (28%) HbA1c levels, AL (38%), and chronic work discrimination (39%; p < .01). Severe chronic work discrimination was associated with elevated HbA1c (relative risk ratio [RRR] = 1.61, 95% confidence interval [CI] = 1.07, 2.43). AL was associated with elevated HbA1c (RRR = 1.49, 95% CI = 1.04, 2.14). Relative to White participants, Hispanic (RRR = 1.52, 95% CI = 1.07, 2.16, RRR = 1.81, 95% CI = 1.051, 3.12), and Black (RRR = 2.42, 95% CI = 1.82, 3.23; RRR = 3.00, 95% CI = 1.97, 4.56) participants had an increased risk of intermediate and elevated HbA1c, respectively. Among those with long job tenure (≥5 years), both moderate (RRR = 1.81, 95% CI = 1.11, 2.96) and severe (RRR = 1.90, 95% CI = 1.15, 3.12) chronic work discrimination was associated with elevated HbA1c. Chronic work discrimination was associated with HbA1c; however, no moderating effects of AL were observed. Findings underscore a need for organizational and public health measures to establish strong anti-discrimination laws in the workplace to improve the work environment of older workers and reducediabetes risk.

Impact of HCV eradication by directly acting antivirals on glycemic indices in chronic hepatitis C patients -a nationwide Taiwan HCV registry

Background/AimsHepatitis C virus (HCV) eradication using antiviral agents augments the metabolic profile. Changes in glycated hemoglobin (HbA1c) levels in chronic hepatitis C patients who receive glecaprevir/pibrentasvir (GLE/PIB) remain elusive. MethodsData from 2417 patients treated with GLE/PIB from the Taiwan HCV Registry were analyzed, and pretreatment HbA1c levels were compared with 3-months after the-end-of treatment levels. A sustained virological response (SVR) was defined as undetectable HCV RNA at 12 weeks after the end of treatment. A significant change in HbA1c level was defined as the 75th percentile of the change in the HbA1c level before and after treatment (decrement >0.2%). ResultsSerum HbA1c levels decreased significantly (6.0 vs 5.9%, P < 0.001). Post-treatment HbA1c levels decreased in all subgroups, except in non-SVR patients (5.7 vs 5.7%, P = 0.79). Compared to patients without significant HbA1c improvement (decrement >0.2%), those with HbA1c improvement were older (60.2 vs 58.6 years, P < 0.001), had higher serum creatinine levels (1.9 vs 1.6 mg/dL, P < 0.001), triglycerides (129.8 vs 106.2 mg/dL, P < 0.001), fasting glucose (135.8 vs 104.0 mg/dL, P < 0.001), and pretreatment HbA1c (7.1 vs 5.7%, P < 0.001) and had a higher proportion of male sex (57.9% vs 50.9%, P = 0.003), diabetes (84.3 vs 16.8%, P < 0.001), more advanced stages of chronic kidney disease (CKD) (15.7 vs 11.1 %, P < 0.001), anti-diabetic medication use (47.3 vs 16.4%, P < 0.001) and fatty liver (49.6 vs 38.3 %, P < 0.001). Multivariate analysis revealed that the factors associated with significant HbA1c improvement were age (odds ratio [OR]/95% confidence intervals [CI]: 1.01/1.00–1.02, P = 0.01), HbA1c level (OR/CI: 2.83/2.48–3.24, P < 0.001) and advanced CKD stages (OR/CI: 1.16/1.05–1.28, P = 0.004). If the HbA1c variable was not considered, the factors associated with significant HbA1c improvement included alanine aminotransferase level (OR/CI, 1.002/1.000–1.004, P = 0.01), fasting glucose level (OR/CI: 1.010/1.006–1.013, P < 0.001), and diabetes (OR/CI: 3.35/2.52–4.45, P < 0.001). ConclusionsThe HbA1c levels improved shortly after HCV eradication using GLE/PIB. The improvement in glycemic control can be generalized to all subpopulations, particularly in patients with a higher baseline HbA1c level or diabetes.

Effect of hemoglobin A1c change on 24-month clinical outcomes in patients with diabetes after acute myocardial infarction.

The average glycated hemoglobin (HbA1c) may not accurately reflect glycemic control status during the mid-term after acute myocardial infarction (AMI). We aimed to evaluate changes in HbA1c and their effect on mid-term clinical outcomes in patients with diabetes and AMI. We enrolled patients with diabetes ( n = 967) who underwent HbA1c measurement in the Korean nationwide registry. These patients were categorized into three groups based on changes in HbA1c from index admission to the 1-year follow-up visit: a decrease in HbA1c > 1%, changes in HbA1c within 1%, and an increase in HbA1c > 1%. Clinical outcomes at 24 months were examined. The baseline HbA1c levels were 8.55 ± 0.85, 7.00 ± 0.98 and 7.07 ± 1.05 ( P = 0.001) and HbA1c levels after 1 year were 6.62 ± 0.73, 7.05 ± 0.98 and 9.26 ± 1.59 ( P = 0.001) for patients with 3 groups, respectively. Patients with a 1% decrease in HbA1c had significantly lower incidence of major adverse cardiovascular events (MACE), cardiac death, and rehospitalization after 24 months than those with a 1% increase in HbA1c. However, in the Cox regression analysis, a >1% decrease in HbA1c change was not an independent factor for MACE, cardiac death, and rehospitalization. Our analysis indicates that an HbA1c decrease of >1% within the first 12 months was not an independent prognostic factor until the 24-month mark. Therefore, standard diabetic control is recommended for patients with diabetes and AMI for up to 2 years.

The psychosocial outcomes of advanced hybrid closed-loop system in children and adolescents with type 1 diabetes

The study was carried out to determine the psychosocial outcomes of advanced hybrid closed-loop (AHCL) systems in children and adolescents with type 1 diabetes (T1D). Single-center and cohort study with a duration 6 months consisted of 60 children and adolescents with T1D. Standard clinical procedures, including both glycemic indicators, e.g., sensor-measured time within the 70–180 mg/dL range and glycated hemoglobin (HbA1c) levels, and psychosocial metrics were used for data collection. The psychosocial metrics included the Pediatric Quality of Life Inventory (PedsQL) 3.0 Diabetes Module for both children (8–12 years) and parents; the Quality of Life for Youth scale for adolescents (13–18 years); the Strengths and Difficulties Questionnaire (SDQ); the Hypoglycemia Fear Survey for Children (HFS-C); the Revised Child Anxiety and Depression Scale (R-CADS); and AHCLS-specific DTSEQ satisfaction and expectation survey. These metrics were evaluated at the baseline and after 6 months of AHCL use. Of the 60 children and adolescents with T1D for whom the AHCL system was utilized, 41 of them, 23 female and 18 male, completed the surveys. The mean age of the 41 children and adolescents was 12.5 ± 3.2 (min. 6.7, max. 18) years. The time spent within the target glycemic range, i.e., time-in-range (TIR), improved from 76.9 ± 9% at the baseline to 80.4 ± 5% after 6 months of AHCL system use (p = 0.03). Additionally, HbA1c levels reduced from 7.1% ± 0.7% at the baseline to 6.8% ± 0.8% after 6 months of AHCL system use (p = 0.03). The most notable decline in HbA1c was observed in participants with higher baseline HbA1c levels. All patients’ HFS-C and AHCL system-specific DTSEQ satisfaction and expectation survey scores were within the normal range at the baseline and remained unchanged during the follow-up period. No significant difference was found in the R-CADS scores of children and adolescents between baseline and after 6 months of AHCL system use. However, there was a significant decrease in the R-CADS scores of the parents. Patients’ PedsQL scores were high both at the baseline and after 6 months. The SDQ scores were high at baseline, and there was no significant improvement at the end of 6 months. Conclusion: This is the first study to investigate in detail the psychosocial outcomes of AHCL system use in T1D patients and their parents. Although state-of-the-art technologies such as AHCL provide patients with more flexibility in their daily lives and information about glucose fluctuations, the AHCL resulted in a TIR above the recommended target range without a change in QOL, HFS-C, SDQ, and R-CADS scores. The scores obtained from the R-CADS conducted by the parents of the children indicated that the use of pumps caused a psychological improvement in the long term, with a significant decrease in the R-CADS scores of the children and adolescents with T1D.What is Known:• Previous studies focused on clinical outcomes of AHCL systems in pediatric T1D patients, showing glycemic control improvements.• Limited attention given to psychosocial outcomes of AHCL systems in children and adolescents with T1D.• Crucial psychosocial factors like quality of life, emotional well-being, and fear of hypoglycemia underexplored in AHCL system context.What is New:• First study to comprehensively examine psychosocial outcomes of AHCL systems in pediatric T1D patients.• Study's robust methodology sets new standard for diabetes technology research and its impact on qualiy of life.

Effects of a diverse prebiotic fibre supplement on HbA1c, insulin sensitivity and inflammatory biomarkers in pre-diabetes: a pilot placebo-controlled randomised clinical trial.

Prebiotic fibre represents a promising and efficacious treatment to manage pre-diabetes, acting via complementary pathways involving the gut microbiome and viscosity-related properties. In this study, we evaluated the effect of using a diverse prebiotic fibre supplement on glycaemic, lipid and inflammatory biomarkers in patients with pre-diabetes. Sixty-six patients diagnosed with pre-diabetes (yet not receiving glucose-lowering medications) were randomised into treatment (thirty-three) and placebo (thirty-three) interventions. Participants in the treatment arm consumed 20 g/d of a diverse prebiotic fibre supplement, and participants in the placebo arm consumed 2 g/d of cellulose for 24 weeks. A total of fifty-one and forty-eight participants completed the week 16 and week 24 visits, respectively. The intervention was well tolerated, with a high average adherence rate across groups. Our results extend upon previous work, showing a significant change in glycated haemoglobin (HbA1c) in the treatment group but only in participants with lower baseline HbA1c levels (< 6 % HbA1c) (P = 0·05; treatment -0·17 ± 0·27 v. placebo 0·07 ± 0·29, mean ± sd). Within the whole cohort, we showed significant improvements in insulin sensitivity (P = 0·03; treatment 1·62 ± 5·79 v. placebo -0·77 ± 2·11) and C-reactive protein (P FWE = 0·03; treatment -2·02 ± 6·42 v. placebo 0·94 ± 2·28) in the treatment group compared with the placebo. Together, our results support the use of a diverse prebiotic fibre supplement for physiologically relevant biomarkers in pre-diabetes.

Baseline glycated albumin level and risk of type 2 diabetes mellitus in Healthy individuals: a retrospective longitudinal observation in Korea

Glycated albumin (GA) reflects glycemic status for the past three weeks. GA level demonstrates a strong correlation with HbA1c level and is used as an adjunctive biomarker for diagnosis and monitoring of type 2 diabetes mellitus (T2DM). In this study, we validated the predictive performance of baseline GA for development of T2DM in healthy individuals in Korea. From August 2013 to September 2014, the medical records of 3,771 healthy Koreans were retrospectively reviewed. Each participant was categorized into tertiles based on initial GA level. During the follow-up period through May 2020, study participants were evaluated for T2DM using HbA1c, fasting glucose level, and a self-reported diagnosis history. Baseline GA level by tertile (T1 to T3) was 10.4 ± 0.8% (mean ± SD), 12.1 ± 0.3%, and 13.7 ± 0.9%, respectively. The median follow-up was 5.97 years, during which 4.9% (186 of 3,771) of the participants developed T2DM. After adjusting for confounding factors, the hazard ratio for the development of T2DM in the highest GA level group (T3) compared to the reference group (T1) was 2.46 (95% CI, 1.7 to 3.58, p < 0.001 for trend) with a Harrell’s C index of 0.80 (95% CI, 0.76 to 0.83). Also, within highest group of baseline HbA1c and FG levels, higher GA levels were associated with an increased HRs for T2DM. In conclusion, Our study confirms that the risk of T2DM increases with baseline GA level. Additional follow-up of the cohort is warranted to investigate the correlations between GA and other clinical indicators including diabetic complications.

Effectiveness and safety of glucagon-like peptide 1 receptor agonists in patients with type 2 diabetes: evidence from a retrospective real-world study.

Global phase III clinical trials have shown superior hypoglycemic efficacy to insulin and other oral hypoglycemic agents. However, there is a scarcity of real-world data comparing different glucagon-like peptide 1 receptor agonist (GLP-1RA) directly. This study aimed to assess the safety and effectiveness of various GLP-1RA in treating type 2 diabetes mellitus (T2DM) in a real-world clinical setting and identify predictive factors for favorable treatment outcomes. This was a retrospective, single-center, real-world study. The changes in HbA1c, fasting plasma glucose (FPG), body weight, systolic blood pressure (SBP), diastolic blood pressure (DBP), and the percentage of participants who achieved HbA1c of <7%, 7%-8%, and ≥ 8% after GLP-1RA treatment was analyzed. The clinical factors that affect the effectiveness of GLP-1RA were analyzed. At baseline, the 249 participants had a mean baseline HbA1c of 8.7 ± 1.1%. After at least three months of follow-up, the change in HbA1c was -0.89 ± 1.3% from baseline. Dulaglutide exerted a more significant hypoglycemic effect than immediate-release exenatide. The percentage of participants who achieved HbA1c<7% was substantial, from 6.0% at baseline to 28.9%. Average body weight decreased by 2.02 ± 3.8 kg compared to baseline. After GLP-1RA treatment, the reduction in SBP was 2.4 ± 7.1 mmHg from baseline. A shorter duration of diabetes and a higher baseline HbA1c level were more likely to achieve a good response in blood glucose reduction. This study provided real-world evidence showing that GLP-1RA significantly improved HbA1c, body weight, and SBP. The results can inform the decision-making about GLP-1RA treatment in daily clinical practice.